search
Back to results

Sulfur Amino Acids, Energy Metabolism and Obesity (STAY)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Low SAA diet
High SAA diet
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Methionine, Cysteine, Sulfur amino acids, Dietary intervention, Plant-based diet

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy participants with overweight and obesity (BMI 27-35 kg/m2)
  • Waist circumference > 80 cm for women and > 94 cm for men

Exclusion Criteria:

  • Smoking
  • Presence of chronic disease
  • Established co-morbidities
  • Already on a vegan diet or have been the last month
  • Pregnancy
  • Breastfeeding the last 3 months
  • Unstable body weight the last 3 months
  • High intensity training > 3 times weekly

Sites / Locations

  • Centre for Clinical Nutrition, University of Oslo/Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low SAA diet

High SAA diet

Arm Description

Dietary intervention

Dietary intervention

Outcomes

Primary Outcome Measures

Changes in body weight
Kilograms

Secondary Outcome Measures

Changes in resting energy expenditure
Kilocalories
Changes in substrate oxidation
Respiratory quotient
Changes in body composition
Fat mass (kilograms) and lean mass (kilograms)
Changes in plasma concentrations of SAA and related intermediates and compounds
Sulfite, thiosulfate, rhodanide, sulfate, total aminothiols (homocysteine, cysteine, glutathione gamma-glutamylcysteine, cysteinylglycine, cysteamine), and fractions of total cysteine, total glutathione and total homocysteine, cystathionine, lanthionine, homolanthionine, taurine hypotaurine, sarcosine, hydrogen sulfide, S-adenosylmethionine and S-adenosylhomocysteine
Changes in urine concentrations of SAA and related intermediates and compounds
Including sulfite, thiosulfate, rhodanide, sulfate, total aminothiols (homocysteine, cysteine, glutathione gamma-glutamylcysteine, cysteinylglycine, cysteamine)
Changes in concentrations of plasma lipid profile
Fatty acids, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, ApoA1, ApoB
Changes in plasma makers of insulin sensitivity
Concentrations of glucose and insulin
Changes in plasma concentrations of adipokines and appetite hormones
Leptin, adiponectin, gastrin, ghrelin, cholecystokinin (CCK), glucagon-like peptide (GLP-1), oxyntomodulin, gastric inhibitory peptide (GIP), peptide YY (PYY), and pancreatic peptide (PP).
Changes in gene expression
mRNA of proteins involved in SAA metabolism, lipid and energy metabolism in leucocytes and subcutaneous white adipose tissue samples
Vitamin status
Plasma concentrations of folate, B12 and methylmalonic acid (MMA)
Changes in biomarkers related to obesity and energy metabolism
Untargeted analyses of plasma, serum and tissue concentrations
Changes in fibroblast growth factor 21 (FGF21)
Serum concentrations
Nitrogen balance
24 h-urine urea nitrogen
Changes in gut microbiota
Sequencing of fecal samples
Changes in short chain fatty acids
Fecal concentrations

Full Information

First Posted
January 5, 2021
Last Updated
May 18, 2022
Sponsor
University of Oslo
Collaborators
Charles University, Czech Republic, Maastricht University, University of Oxford
search

1. Study Identification

Unique Protocol Identification Number
NCT04701346
Brief Title
Sulfur Amino Acids, Energy Metabolism and Obesity
Acronym
STAY
Official Title
Dietary Sulfur Amino Acid Restriction, Energy Metabolism and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 17, 2022 (Actual)
Study Completion Date
March 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Charles University, Czech Republic, Maastricht University, University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of the trial is to establish the effects of dietary sulfur amino acid (SAA) restriction on body weight, body composition and energy expenditure in humans.
Detailed Description
Dietary SAA restriction is an established model for increasing lifespan and improving metabolic health in animal studies. Data from human studies are limited. In this study the investigators will perform an 8-week dietary intervention with SAA restriction to characterise the effects on several parameters related to metabolic health including body weight, body composition, energy expenditure, lipid profile and gene expression profiles in adipose tissue. The aim is to translate findings from previous animal experiments to humans

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Methionine, Cysteine, Sulfur amino acids, Dietary intervention, Plant-based diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low SAA diet
Arm Type
Experimental
Arm Description
Dietary intervention
Arm Title
High SAA diet
Arm Type
Active Comparator
Arm Description
Dietary intervention
Intervention Type
Other
Intervention Name(s)
Low SAA diet
Intervention Description
Diet with low content of methionine and cysteine
Intervention Type
Other
Intervention Name(s)
High SAA diet
Intervention Description
Diet with high content of methionine and cysteine
Primary Outcome Measure Information:
Title
Changes in body weight
Description
Kilograms
Time Frame
At baseline, 4 and 8 weeks
Secondary Outcome Measure Information:
Title
Changes in resting energy expenditure
Description
Kilocalories
Time Frame
At baseline, 4 and 8 weeks
Title
Changes in substrate oxidation
Description
Respiratory quotient
Time Frame
At baseline, 4 and 8 weeks
Title
Changes in body composition
Description
Fat mass (kilograms) and lean mass (kilograms)
Time Frame
At baseline, 4 and 8 weeks
Title
Changes in plasma concentrations of SAA and related intermediates and compounds
Description
Sulfite, thiosulfate, rhodanide, sulfate, total aminothiols (homocysteine, cysteine, glutathione gamma-glutamylcysteine, cysteinylglycine, cysteamine), and fractions of total cysteine, total glutathione and total homocysteine, cystathionine, lanthionine, homolanthionine, taurine hypotaurine, sarcosine, hydrogen sulfide, S-adenosylmethionine and S-adenosylhomocysteine
Time Frame
At baseline, 4 and 8 weeks
Title
Changes in urine concentrations of SAA and related intermediates and compounds
Description
Including sulfite, thiosulfate, rhodanide, sulfate, total aminothiols (homocysteine, cysteine, glutathione gamma-glutamylcysteine, cysteinylglycine, cysteamine)
Time Frame
At baseline, 4 and 8 weeks
Title
Changes in concentrations of plasma lipid profile
Description
Fatty acids, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, ApoA1, ApoB
Time Frame
At baseline, 4 and 8 weeks
Title
Changes in plasma makers of insulin sensitivity
Description
Concentrations of glucose and insulin
Time Frame
At baseline, 4 and 8 weeks
Title
Changes in plasma concentrations of adipokines and appetite hormones
Description
Leptin, adiponectin, gastrin, ghrelin, cholecystokinin (CCK), glucagon-like peptide (GLP-1), oxyntomodulin, gastric inhibitory peptide (GIP), peptide YY (PYY), and pancreatic peptide (PP).
Time Frame
At baseline, 4 and 8 weeks
Title
Changes in gene expression
Description
mRNA of proteins involved in SAA metabolism, lipid and energy metabolism in leucocytes and subcutaneous white adipose tissue samples
Time Frame
At baseline, 4 and 8 weeks
Title
Vitamin status
Description
Plasma concentrations of folate, B12 and methylmalonic acid (MMA)
Time Frame
At baseline, 4 and 8 weeks
Title
Changes in biomarkers related to obesity and energy metabolism
Description
Untargeted analyses of plasma, serum and tissue concentrations
Time Frame
At baseline, 4 and 8 weeks
Title
Changes in fibroblast growth factor 21 (FGF21)
Description
Serum concentrations
Time Frame
At baseline, 4 and 8 weeks
Title
Nitrogen balance
Description
24 h-urine urea nitrogen
Time Frame
At baseline, 4 and 8 weeks
Title
Changes in gut microbiota
Description
Sequencing of fecal samples
Time Frame
At baseline, 4 and 8 weeks
Title
Changes in short chain fatty acids
Description
Fecal concentrations
Time Frame
At baseline, 4 and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy participants with overweight and obesity (BMI 27-35 kg/m2) Waist circumference > 80 cm for women and > 94 cm for men Exclusion Criteria: Smoking Presence of chronic disease Established co-morbidities Already on a vegan diet or have been the last month Pregnancy Breastfeeding the last 3 months Unstable body weight the last 3 months High intensity training > 3 times weekly
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjetil Dr Retterstøl, Prof. dr med
Organizational Affiliation
University of Oslo
Official's Role
Study Director
Facility Information:
Facility Name
Centre for Clinical Nutrition, University of Oslo/Oslo University Hospital
City
Oslo
ZIP/Postal Code
0372
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
EU privacy regulations do not permit public sharing of IPD as long as the project is ongoing. Anonymized data can be shared after the project and biobank permissions end in 2030. The study protocol will be published.
Citations:
PubMed Identifier
33858441
Citation
Stolt E, Olsen T, Elshorbagy A, Kozich V, van Greevenbroek M, Ovrebo B, Thoresen M, Refsum H, Retterstol K, Vinknes KJ. Sulfur amino acid restriction, energy metabolism and obesity: a study protocol of an 8-week randomized controlled dietary intervention with whole foods and amino acid supplements. J Transl Med. 2021 Apr 15;19(1):153. doi: 10.1186/s12967-021-02824-3.
Results Reference
derived

Learn more about this trial

Sulfur Amino Acids, Energy Metabolism and Obesity

We'll reach out to this number within 24 hrs